MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ PACING TD CATHETER; ELECTRODE, PACEMAKER, PERMANENT

Model Number D200F7

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.No corrective actions will be taken at this time.Lot number was not provided; therefore review of the manufacturing records could not be completed.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.Due to the knotting of the catheter it should be noted that the ifu indicates that catheter looping may occur when excessive length has been inserted, which could result in kinking or knotting.If the right ventricle is not entered after advancing the catheter 15 cm beyond entry into the right atrium, the catheter may be looping, or the tip may be engaged in the neck of the vein with only the proximal shaft advancing into the heart.Deflate the balloon and withdraw the catheter until the 20 cm mark is visible.Re-inflate the balloon and advance the catheter.Flexible catheters have been reported to form knots, most often as a result of looping in the right ventricle.Sometimes the knot can be resolved by insertion of a suitable guidewire and manipulation of the catheter under fluoroscopy.If the knot does not include any intracardiac structures, the knot may be gently tightened, and the catheter withdrawn through the site of entry.In this case, a new catheter was inserted with a new insertion site in order to maintain hemodynamic monitoring.Ultimately, a resternotomy was performed to remove the catheter, due to the suturing to the heart.The ifu states that vessel perforation/damage may occur as a result of suturing the pulmonary artery catheter into a surrounding structure.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

Event Description

In a journal article titled " accidental entrapment of a pulmonary artery catheter during heart transplantation", it was reported that during a heart transplant surgery of a 37 year old male patient, using a swan-ganz catheter, no right ventricular or pulmonary artery pressure curve could be displayed.The attempt to use the pressure curve to flush the pah into the pulmonary artery was unsuccessful despite multiple attempts with a problem-free catheter advance.When trying to withdraw the catheter further than 18 cm, a resilient resistance was found.Then, a transesophageal echocardiography (tee) was performed and it failed to show the pah due to artifacts.In order to ensure continuous monitoring of the right ventricular function, a further 8.5 f sheath was easily placed in the right internal jugular vein, which enabled the introduction of a second pah into the pulmonary artery flow.This swan-ganz catheter was introduced to a depth of 13 cm with the aid of a non-edwards protective sheath (arrow®) and locked there in the sheath.This was estimated to be a safe distance from the cannulation site in the superior vena cava to avoid fixation.The catheters already lying on the right side of the body were each withdrawn by approx.5 cm.As per further consultation with the surgeon, the possibility of accidental suture fixation was considered, but other causes seemed more likely (knot formation, obstruction of the sheath).Therefore, a postoperative imaging for further evaluation was agreed.On the first postoperative day, two chest x-rays were taken, which on the one hand showed a looping of the first pah introduced from the left with the catheter being advanced, with a presumed transition point at the level of the superior vena cava.On the other hand, after withdrawal of the catheter until resistance occurred, the catheter was normal without a loop.An additional intervention was required in order to remove the swan-ganz catheter introduced on the left side.First, the probing was carried out with a guide wire under fluoroscopy (fluoroscopy), during which the loop formation was confirmed by a fixation in the area of the superior vena cava when the catheter was advanced and traction was transmitted to the whole heart when the patient withdrew from 18 cm.This strengthened the suspicion that the catheter was being fixed in the area of the upper venous cannulation site.This was followed by the resternotomy and the loosening of a suture at the cannulation site, after which the catheter could be completely removed without any problems.After removal, two perforation sites were clearly visible in the distal section of the catheter.Although a new insertion site was used and they had to loosen the sternotomy site sutures to fix the issue causing an additional 45 minute procedure, the patient suffered no relevant blood loss.The patient did not suffer from any consequential damage.Fortunately, the immediate further course was uneventful with good transplant function.This enabled the patient to be extubated quickly and transferred to the cardiosurgical "intermediate care" ward on the 5th postoperative day.The catecholamine therapy declined rapidly and could be tapered off quickly.The neurological status was unchanged from the preoperative findings.After 2 weeks, the patient was in good general condition and moved close to home for further inpatient treatment.An additional intervention was needed to avoid patient injury due to the multiple complications and not due to the performance of the device.The device is not available for examination.

• Brand Name: SWAN-GANZ PACING TD CATHETER
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): EDWARDS LIFESCIENCES; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 11041755
• MDR Text Key: 223598433
• Report Number: 2015691-2020-15121
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K791183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D200F7
• Device Catalogue Number: D200F7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37
• Patient Weight: 50